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Original Articles
A Multicenter, Double Blind, Comparative Study of the Efficacy and Safety of Terbinafine 250mg/day for 12 weeks Versus Itraconazole 100mg/day for 24 weeks in the Traeatment of Patients with Onychomychosis
Ki-Hong Kim1, Jong Soo Choi1, Joon Young Song2, Sang-Won Kim3, Soo Chan Kim4, Sung gu Ahn5, Yul Oh Sung6, Soon Bong Suh7
Departments of Dermatology, College of Medicine, Yeungnam University1, Keimyung University2, Taegu Catholic University3, Yonsei University4, Wonju Christian Hospital Yonsei University5, Dongguk University6 and Catholic Skin Clinic7
Vol.13 Num.2 (p165~175)
In this randomized double-blind trial on multicenter study, the efficacy of the new antifungal agent, terbinafine(Lamisil) was compared with the triazole antifungal agent, itraconazole, in the treatment of patients with onychomychosis.
One hundred and forty nine patients(74 terbinafine, 75 itraconazole) with onychomychosis were enrolled. Twenty five patients were lost to follow-up and 13 reported adverse reaction with premature discontinuation of therapy.
And 111 patients were eligible for follow-up until 36 weeks after starting the treatment. Fifty one patients received Lamisil(terbinafine) 250mg daily for twelve weeks (terbinafine group) and 60 received itraconazole 100mg daily for 24 weeks(itraconazole group). They were checked clinical symptoms(onycholysis, subungual hyperkeratosis, paronychyal inflammation, color change, brittleness, ridging, normal length of nails) and mycological improvement with KOH wet mount and culture during the study.
Clinical improvements were slow but progressive. In terbinafine group of 51 patients, 24 patients(47.0%) were completely cleared and 18 patients (35.3%) were improved more than 76%, and 6 patients(11.8%) were improved in 51~75%. In itraconazole group of 60 patients, 27 patients(45.0%) were completely cleared and 14 patients(23.3%) were improved more than 76%, and 9 patients(150%) were improved in 51~75%.
In mycologic study, cure rate of the terbinafine group showed all negative at 36 weeks after the treatment while itraconazole group showed all negative in culture but negative KOH in 98.3%.
Adverse reactions and tolerability of both the drugs were good and not different significnatly.
All these findings suggest that the efficacyt of Lamisil(terbinafine) 250mg daily for 12 weeks in the treatment of onychomycosis was similar to that of itraconazole 100mg daily for 24 weeks.
Keywords : Onychomycosis, Itraconazole, Terbincfine